Setting Up Data Clarification Forms (DCFs)
Oracle Clinical includes a utility for printing and tracking Data Clarification Forms (DCFs) as a way of resolving discrepancies in a clinical trial's response data. Setting up DCFs for your organization requires that you define DCF status codes and lay out the DCF report.
For more information, see:
- Defining DCF Statuses and their Behavior
- Laying Out the DCF
- Replacing the Placeholder DCF Logo Graphic
- Customizing and Upgrading DCF Reports
Parent topic: Configuring Discrepancy Management
Defining DCF Statuses and their Behavior
There are several Installation Reference Codelists that affect DCF Statuses. You can modify them to for your organization's needs. See the following:
Parent topic: Setting Up Data Clarification Forms (DCFs)
DCF STATUS CODES
The DCF Status reflects the stage in the review process of the DCF as a whole. Oracle Clinical comes with many review statuses defined in this reference codelist. You can make them inactive if you do not want to use them or create new ones, with the following limitations:
-
You cannot make these statuses inactive: Sent, Received, and Closed.
-
Do not make status Created inactive unless you also make it optional in the DCF OPTIONAL STATUS CODES reference codelist.
-
Do not make statuses Incomplete, Part Received, or Received inactive if you want the system to automatically update the DCF Status when users update the status of individual DCF Pages.
-
If you add a status, you must set its DISPLAY_SN, which determines the order in which the statuses can be set. If you adjust the DISPLAY_SN, you may need to adjust the DCF LOCK CONDITIONS and the DCF OPTIONAL STATUS CODES installation reference codelists, both of which refer to DCF Statuses by their number in the DCF STATUS CODES installation reference codelist.
Parent topic: Defining DCF Statuses and their Behavior
DCF OPTIONAL STATUS CODES
This installation reference codelist refers to the DCF Statuses listed in the DCF STATUS CODES reference codelist. The number in the Short Value column refers to the display number of the status in the DCF STATUS CODES codelist. (Note that the description is incorrect for numbers 7 and 8, which should be Incomplete and Part Received.)
All status codes referenced and active in this codelist are optional. All that are inactive or not entered here are mandatory, meaning that a DCF must be assigned to that status before it can be assigned a subsequent status, as defined in the Seq column. As shipped, only CREATED, SENT and CLOSED are mandatory (no rows exist with short values 2, 6, or 12).
To make a status mandatory if it is included in this reference codelist, uncheck its Active box.
Parent topic: Defining DCF Statuses and their Behavior
DCF LOCK CONDITIONS
This installation reference codelist determines what actions can be taken on discrepancies and DCFs where the DCF has a particular status. The Long Value refers to the number of the status in the DCF STATUS CODES codelist. As shipped, the codelist sets the following behavior, in order:
-
Discrepancies belonging to a DCF whose status is Final (#4) or higher cannot be deleted.
-
Discrepancies belonging to a DCF whose status is Ready (#5) or higher cannot be modified.
-
DCFs whose status is Ready (#5) or higher cannot be deleted (unless the status exceeds or equals a status with a DISPLAY_SN of 1000; see last point).
-
DCFs whose status is Ready (#5) or higher cannot be modified.
-
DCFs whose status is #1000 or higher cannot be closed. Oracle recommends that you do not change DCF_CLOSE.
To stop enforcing any of these rules, set the Long Value to a high value. To change the DCF Status that prevents any of the actions described in the Short Value column, change the number in the Long Value column to the number in the DCF STATUS CODES codelist of the status you prefer.
Parent topic: Defining DCF Statuses and their Behavior
Laying Out the DCF
OPA views dcf_rpt_master
and dcf_rpt_detail
control much of the content and the appearance of DCFs. Local codelist DCF REPORT LABELS controls the report's label text. DCFs also include several unchangeable parameters, such as the Revision # and other values that print along the bottom of each DCF page.
For laying out the DCF's contents and arranging its fields, and view a geographic representation of the DCF's default values and their placements, see:
- Replacing the DCF Placeholder Graphic
- Modifying Codelist DCF REPORT LABELS
- Modifying the DCF Views
- Defining DCF Headers and Footers
- Default DCF Layout Diagram
Parent topic: Setting Up Data Clarification Forms (DCFs)
Replacing the DCF Placeholder Graphic
Oracle Clinical includes a placeholder graphic file located, typically, in your installation's ..\OPA
release_number
\oc
directory, and named rxcdcf.bmp
. You can replace rxcdcf.bmp
with your own graphic file, but you must name it rxcdcf.bmp
. Oracle recommends that your graphic does not exceed 200 pixels in height.
Parent topic: Laying Out the DCF
Modifying Codelist DCF REPORT LABELS
The labels for the value fields of the DCF views correspond to their position on the report. The following table describes each of the columns on the report. For field labels, it identifies the codelist member in the DCF REPORT LABELS local codelist and their default table and column values.
Table 3-24 DCF Labels and Field Mappings
Default Field Label from DCF_REPORT_LABELS Short Value | Default Field Label from DCF_REPORT_LABELS Long Value | Default Data Value from DCF_RPT_MASTER and DCF_RPT_DETAIL Table.Column | Default Data Value from DCF_RPT_MASTER and DCF_RPT_DETAIL Description |
---|---|---|---|
line1_left |
To: |
ocl_sites.name |
Site name's short value |
line3_left |
Date: |
sysdate |
Date of this DCF's creation: mm/dd/yyyy |
line3_right |
Reviewer |
oracle_accounts.firstname (and) .lastname |
Reviewer's initials |
line2_left |
Investigator: |
ocl_investigators.first_name (and) .lastname |
Investigator's first and last name. |
line1_right |
Patient #: |
patient_positions.patient |
Patient position |
line2_right |
Patient Initials: |
patient_positions.reported_first_name (and) .reported_last_name |
Patient's initials |
q_field1 |
Form Name/Visit Name: |
dcms.description |
Mapped to view value qline1_1 |
q_field2 |
Page #: |
discrepancy_entries.crf_page_number |
CRF page numberMapped to view value qline1_2 |
q_field3 |
Date: |
discrepancy_entries.creation_ts |
Discrepancy time stamp date: mm/dd/yyyyMapped to view value qline1_3 |
q_field4 |
Questions/Comments: |
dcf_discrepancies.comment_text |
Mapped to view value qline1_4 |
q_field5 |
Resolution: |
dcf_discrepancies.resolution_text |
Mapped to view value qline1_5 |
mstr_sort_orderFoot 1 |
line1_right |
patient_positions.patient |
Controls the default sort order of view DCF_RPT_MASTER |
dtl_sort_order1 |
q_line1_1 |
dcm.description |
Controls the default sort order of view DCF_RPT_DETAIL |
rpt_orientation1 |
|
- |
Landscape or Portrait Controls the default action of the Print button in the DCF form. |
Footnote 1
Not a label
Parent topic: Laying Out the DCF
Modifying the DCF Views
The following tables describe all of the parameters in the two DCF report views. The view scripts for the DCF are in file rxcviews.sql. You can map other discrepancy values to the DCF parameters, or comment out the parameters to remove them from the DCF output. Note that if you remap parameters, you may have to change their labels (See Modifying Codelist DCF REPORT LABELS.)
Caution:
Do not change parameter values that have a
_DNC
suffix.
Table 3-25 View DCF_RPT_MASTER Parameters
Parameter | Default Data Value (Table.Column) | Comments |
---|---|---|
dcf_id_dnc |
data_clarification_forms.dcf_id |
A system-generated number. |
title1 |
clinical_studies.short_title |
Prints the study's title. |
title2 |
'Data Clarification Form' |
Prints the text string Discrepancy Clarification Form. |
line1_left |
ocl_sites.name |
Site name's short value |
line3_left |
sysdate |
Date of this DCF's creation: MM/DD/YYYY |
line3_right |
oracle_accounts.firstname and .lastname |
DCF creator's account name |
line2_left |
ocl_investigators.first_name (and) .lastname |
Investigator's first and last name. |
line1_right |
patient_positions.patient |
Patient position |
line2_right |
patient_positions.reported_first_name (and) reported_last_name |
Patient's initials |
header_text |
header_text |
Prints the discrepancy's header text. Define header text in the Standard Text Maintenance form. |
footer_text |
footer_text |
Prints the discrepancy's footer text. Define footer text in the Standard Text Maintenance form |
clinical_study_id_dnc |
clinical_studies.clinical_study_id |
- |
current_status_dnc |
data_clarification_forms.current_status |
- |
site_id_dnc |
data_clarification_forms.site_id |
- |
investigator_id_dnc |
ocl_investigators.first_name (and) .last_name |
Investigator's initials |
owning_user_dnc |
data_clarification_forms.owning_user |
- |
The following table describes the values of the DCF_RPT_DETAIL view, and its default data values. In DCF report printouts, the system draws a rectangular border around the output of this view, and may include more than one discrepancy's details.
Table 3-26 View DCF_RPT_DETAIL Parameters
View Parameter | Default Data Value (Table.Column) | Comments |
---|---|---|
dcf_id_dnc |
data_clarification_forms.dcf_id |
- |
q_line1_1 |
dcms.description |
Value for q_field1 label |
q_line1_2 |
discrepancy_entries.crf_page_number |
Value for q_field2 label |
q_line1_3 |
received_dcms.dcm_date |
Value for q_field3label |
q_line1_4 |
dcf_discrepancies.comment_text |
Value for q_field4label |
q_line1_5 |
dcf_discrepancies.resolution_text |
Value for q_field5label |
q_line2_1 |
clinical_planned_events.description |
- |
discrepancy_entry_id_dnc |
discrepancy_entries.discrepancy_entries |
- |
status_dnc |
dcf_discrepancies.status |
- |
disc_type |
discrepancy_entries.de_sub_type_code |
- |
disc_rev |
discrepancy_entries.discrepancy_rev_status |
- |
Parent topic: Laying Out the DCF
Defining DCF Headers and Footers
You can define standard text headers and footers in the Standard Text Maintenance form (see Creating New Standard Text). You can define any number of standard headers and footers and designate one header and one footer as the default. When you create a DCF, the system assigns it the default header and footer. You can use the list of values in the Header and Footer fields to choose a different standard header or footer.
You can also modify the standard text of the header or footer by clicking the Text button in the main DCF screen and editing the displayed text.
Parent topic: Laying Out the DCF
Default DCF Layout Diagram
The following diagram shows the relative position of the labels (in bold font), and the default data values of a default DCF printout. The section between the rxcdcf.bmp graphic and the ruled rectangle contains most of the data defined in the DCF_RPT_MASTER view. The DCF_RPT_DETAIL view populates the contents in the rectangle. A DCF can accommodate the descriptions of more than one discrepancy on each page. The legend for the DCF layout diagram precedes the diagram itself.
Parent topic: Laying Out the DCF
Replacing the Placeholder DCF Logo Graphic
The Oracle Clinical Data Clarification Form (DCF) report includes a bitmap image on the cover page.
You can replace the default image with your own graphic or logo, or you can use a graphics application to redraw the image.
The source file for the bitmap image is at the following location on Oracle Clinical Reports Server installations:
OPA_HOME/oc/rxcdcf.bmp
You can edit the image locally and then copy it to your server.
Parent topic: Setting Up Data Clarification Forms (DCFs)
Customizing and Upgrading DCF Reports
For DCF Reports, you can customize the following files:
-
rxcdrptl.rdf
-
rxcdrptp.rdf
These source files are located on the Forms Server in the following directory:
OPA_HOME/oc/admin
Parent topic: Setting Up Data Clarification Forms (DCFs)